Source document or public record
FDA 510(k) K193490 — SensiTox C. difficile Toxin Test
FDA 510(k) index record K193490. Device: SensiTox C. difficile Toxin Test. Applicant as listed: First Light Diagnostics, Inc.. Decision date: 2021-07-08.
Source
"device_name": "SensiTox C. difficile Toxin Test"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
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Automated FDA record verification
2026-10-20
2026-10-20
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FDA 510(k) public index record K193490.
Device name: SensiTox C. difficile Toxin Test. Applicant as listed: First Light Diagnostics, Inc..
Decision date: 2021-07-08. Decision wording: Substantially Equivalent.
Product code: LLH. Regulation: 21 CFR 866.2660. Medical specialty: Microbiology.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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